Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
Not Applicable
Completed
- Conditions
- Sleep Apnea, ObstructiveSigns and Symptoms, RespiratorySleep Apnea SyndromesRespiration DisordersSyndrome, Obstructive Sleep Apnea
- Interventions
- Device: aura6000 System
- Registration Number
- NCT01532180
- Lead Sponsor
- ImThera Medical, Inc.
- Brief Summary
The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Moderate to severe obstructive sleep apnea (AHI 15 to 60).
- Cannot or will not tolerate CPAP treatment.
- Body mass index (BMI) between 25 and 40
- Able to read, understand, sign and date the written informed consent form
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description THN Therapy aura6000 System -
- Primary Outcome Measures
Name Time Method Adverse events and Serious Adverse events peri and post-operatively 3 and 12 months post-operative Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline. 3 and 12 months post-implant
- Secondary Outcome Measures
Name Time Method Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline. 3 and 12 months post-implantation Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline. 3 and 12 months post-operative
Trial Locations
- Locations (1)
Clinique Univ. Saint-Luc
🇧🇪Brussels, Belgium